FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136657–136680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1988
PICS-2000
K880822 · JAK
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 28, 1988
SOMATOM PLUS
K880965 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 28, 1988
GV 11 (TM), MODEL 9700
K881082 · IPF
Medical Devices, Inc.
Physical Medicine · 14d
Cleared Mar 28, 1988
KINETIC FIBRINOGEN ASSAY
K881150 · GIS
Bio/Data Corp.
Hematology · 11d
Cleared Mar 28, 1988
JOHNSON & JOHNSON FLUFF SPONGE
K881222 · EFQ
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 6d
Cleared Mar 25, 1988
MODEL 5050 SURGILASER FOR UROLOGY USE
K871932 · LNK
Lasermatic, Inc.
Gastroenterology & Urology · 311d
Cleared Mar 25, 1988
MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
K871934 · LNK
Lasermatic, Inc.
Gastroenterology & Urology · 311d
Cleared Mar 25, 1988
DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
K873410 · DXT
Blood Gas Supply Co.
Cardiovascular · 213d
Cleared Mar 25, 1988
PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
K874136 · GWE
Bio-Logic Systems Corp.
Neurology · 164d
Cleared Mar 25, 1988
MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
K875324 · DXT
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 25, 1988
MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
K875327 · DRE
Schneider-Shilley (Usa)
Cardiovascular · 87d
Cleared Mar 25, 1988
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
K880074 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 74d
Cleared Mar 25, 1988
TENDON HARVESTER
K880414 · HRX
Concept, Inc.
Orthopedic · 53d
Cleared Mar 25, 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · DHB
Ventrex Laboratories, Inc.
Immunology · 45d
Cleared Mar 25, 1988
CALCOFLUOR WHITE STAIN KIT
K880718 · JTS
Remel Co.
Pathology · 31d
Cleared Mar 25, 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730 · DCK
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
NOVA LITE(TM) ANA
K880736 · LLL
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
NOVA LITE(TM) DSDNA
K880742 · DHN
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
K880828 · DFT
Wako Chemicals USA, Inc.
Immunology · 24d
Cleared Mar 25, 1988
NOVA GEL(TM) SS-A/SS-B
K880896 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Mar 25, 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · KYZ
Micromedics, Inc.
General Hospital · 15d
Cleared Mar 25, 1988
OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
K881060 · JEA
Orthopedic Systems, Inc.
General & Plastic Surgery · 21d
Cleared Mar 25, 1988
UTILITY CLAMP
K881084 · GDJ
Med-Dex Intl.
General & Plastic Surgery · 11d